NovoRapid 100unitsml solution for injection 10ml vials

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Insulin aspart

Available from:

Novo Nordisk Ltd

ATC code:

A10AB05

INN (International Name):

Insulin aspart

Dosage:

100unit/1ml

Pharmaceutical form:

Solution for injection

Administration route:

Intravenous; Subcutaneous

Class:

No Controlled Drug Status

Prescription type:

VMP not recommended to prescribe - patient training required

Product summary:

BNF: 06010101; GTIN: 5017954000944

Patient Information leaflet

_Approved 26-Apr-2018_
_ _
PACKAGE LEAFLET: INFORMATION FOR THE USER
NOVORAPID® 100 UNITS/ML SOLUTION FOR INJECTION IN VIAL
Insulin aspart
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
•
Keep this leaflet. You may need to read it again.
•
If you have any further questions, ask your doctor, nurse or
pharmacist.
•
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them, even
if their signs of illness are the same as yours.
•
If you get any side effects, talk with your doctor, nurse or
pharmacist. This includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
_1. _
_WHAT NOVORAPID® IS AND WHAT IT IS USED FOR _
_2. _
_WHAT YOU NEED TO KNOW BEFORE YOU USE NOVORAPID® _
_3. _
_HOW TO USE NOVORAPID® _
_4. _
_POSSIBLE SIDE EFFECTS _
_5. _
_HOW TO STORE NOVORAPID® _
_6. _
_CONTENTS OF THE PACK AND OTHER INFORMATION _
_1. _
_WHAT NOVORAPID® IS AND WHAT IT IS USED FOR _
NovoRapid® is a modern insulin (insulin analogue) with a
rapid–acting effect. Modern insulin products are
improved versions of human insulin.
NovoRapid® is used to
REDUCE THE HIGH BLOOD SUGAR LEVEL
in adults, adolescents and children aged 1 year
and above with diabetes mellitus (diabetes). Diabetes is a disease
where your body does not produce
enough insulin to control the level of your blood sugar. Treatment
with NovoRapid® helps to prevent
complications from your diabetes.
NovoRapid® will start to lower your blood sugar 10–20 minutes after
you inject it, a maximum effect
occurs between 1 and 3 hours after the injection and the effect lasts
for 3–5 hours. Due to this short action
NovoRapid® should normally be taken in combination with
intermediate–acting or long–acting insulin
preparations. Moreover NovoRapid® can be used for continuous infusion
in a pump system.
_2. _
_WHAT YOU NEED TO KNOW BEFORE YOU USE NOVORAPID® _
DO NOT USE NOVORAPID®
►
If you are allergic to ins

Summary of Product characteristics

OBJECT 1
NOVORAPID PENFILL 100 UNITS/ML
Summary of Product Characteristics Updated 25-May-2018 | Novo Nordisk
Limited
1. Name of the medicinal product
NovoRapid 100 units/ml solution for injection in vial
NovoRapid Penfill 100 units/ml solution for injection in cartridge
NovoRapid FlexPen 100 units/ml solution for injection in pre-filled
pen
NovoRapid FlexTouch 100 units/ml solution for injection in pre-filled
pen
NovoRapid PumpCart 100 units/ml solution for injection in cartridge
2. Qualitative and quantitative composition
NovoRapid vial
1 vial contains 10 ml equivalent to 1,000 units.1 ml solution contains
100 units insulin aspart* (equivalent
to 3.5 mg).
NovoRapid Penfill
1 cartridge contains 3 ml equivalent to 300 units.1 ml solution
contains 100 units insulin aspart*
(equivalent to 3.5 mg).
NovoRapid FlexPen/NovoRapid FlexTouch
1 pre-filled pen contains 3 ml equivalent to 300 units.1 ml solution
contains 100 units insulin aspart*
(equivalent to 3.5 mg).
NovoRapid PumpCart
1 cartridge contains 1.6 ml equivalent to 160 units.1 ml solution
contains 100 units insulin aspart*
(equivalent to 3.5 mg).
*Insulin aspart is produced in _Saccharomyces cerevisiae_ by
recombinant DNA technology.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Solution for injection.
The solution is clear, colourless and aqueous.
4. Clinical particulars
4.1 Therapeutic indications
NovoRapid is indicated for treatment of diabetes mellitus in adults,
adolescents and children aged 1 year
and above.
4.2 Posology and method of administration
POSOLOGY
The potency of insulin analogues, including insulin aspart, is
expressed in units, whereas the potency of
human insulin is expressed in international units.
NovoRapid dosing is individual and determined in accordance with the
needs of the patient. It should
normally be used in combination with intermediate-acting or
long-acting insulin.
Moreover NovoRapid vial and NovoRapid PumpCart can be used for
continuous subcutaneous insulin
infusion (CSII) in pump systems.
NovoRapid v